Pulmonary Involvement in Scleroderma: A Clinical Study of the Safety and Efficacy of Mycophenolate Mofetil in Scleroderma Patients With Lung Involvement

This study has been completed.

Sponsor:

Collaborator:

Roche Pharma AG

Information provided by (Responsible Party):

Jeff Golden, University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT00333437

First received: June 2, 2006

Last updated: May 6, 2013

Last verified: May 2013

History of Changes

Results First Received: May 6, 2013

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Scleroderma, Systemic
Intervention:	Drug: Study subjects receive standard mycophenolate dosing.

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
8 patients were screened at one clinical site (UCSF) in the United States

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient screened for enrollment did not meet eligibility criteria

Reporting Groups

	Description
Single-group Study Treatment	Study subjects receive standard mycophenolate dosing.

Participant Flow: Overall Study

	Single-group Study Treatment
STARTED	7
COMPLETED	7
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Treatment	Study subjects receive standard mycophenolate dosing.

Baseline Measures

	Treatment
Number of Participants [units: participants]	7
Age [units: participants]
<=18 years	0
Between 18 and 65 years	7
>=65 years	0
Age [units: years] Mean ± Standard Deviation	52.57 ± 7.52
Gender [units: participants]
Female	5
Male	2
Region of Enrollment [units: participants]
United States	7

Outcome Measures

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1. Primary:

Mean Change in Forced Vital Capacity (FVC) [ Time Frame: 12 months ]

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2. Secondary:

Mean Change in Bronchoalveolar Lavage (BAL) Components (Neutrophils, Eosinophils) [ Time Frame: 12 months ]

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3. Secondary:

Improved Shortness of Breath (Self-reported) [ Time Frame: 12 months ]

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4. Secondary:

Mean Change in Six Minute Walk Distance [ Time Frame: 12 months ]

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5. Secondary:

Mean Change in Diffusion Capacity of the Lung for Carbon Monoxide (DLCO) [ Time Frame: 12 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Jeffrey A. Golden, MD
Organization: University of California San Francisco
phone: 415-353-2935
e-mail: Jeff.Golden@ucsf.edu

No publications provided

Responsible Party:	Jeff Golden, University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00333437 History of Changes
Other Study ID Numbers:	CEL371
Study First Received:	June 2, 2006
Results First Received:	May 6, 2013
Last Updated:	May 6, 2013
Health Authority:	United States: Food and Drug Administration

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